Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block - Full Text View

Purpose

Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia.

The aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

Condition	Intervention
Dental Pain	Procedure: Dental anesthesia


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:

To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment. [ Time Frame: 2 years ]


Enrollment:	37
Study Start Date:	October 2009
Study Completion Date:	September 2013
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Quicksleeper intraosseous anesthesia Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous anesthesia.	Procedure: Dental anesthesia Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.
Active Comparator: Inferior alveolar nerve block Pulpal and periapical molar and premolar sedation is managed by inferior alveolar nerve block.	Procedure: Dental anesthesia Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.

Detailed Description:

Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection. Failure rate of local anesthesia highly increases with irreversible pulpitis or inflamed periradicular tissue.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia (from teeth 35 up to 38 and from 45 up to 48).

The primary aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

Four clinical situations are evaluated : pulpitis; periapical abcess; pulpal hyperemia; asymptomatic decayed tooth.

Evaluated parameters are : speed of sedation, ability of cure, additional anesthesia needed, total of needles and cartridges used, side effects. Time and validation of complete anesthesia is controlled by pulp tester.

Studied population is patients cared in restorative, endodontics department.

Pulpal and periapical molar and premolar sedation is randomly managed by inferior alveolar nerve block or Quicksleeper intraosseous anesthesia, among studied population (divided in 2 groups of 50 patients). Pulp-tester measures anesthesia minute by minute.

The comparison of study results to bibliography, guidelines and advantages for using mechanical Quicksleeper anesthesia system will be discussed.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Irreversible pulpitis on second mandibular premolar or mandibular molars
Necessity of pulpotomy or pulpectomy

Exclusion Criteria:

Pregnancy, chest feeding
Non dental emergency state
hypersensibility to local anesthesia
Pheochromocytoma
Irregularity of cardiac rhythm
Myocardial infarct in the 6 previous months
Hepatic porphyria

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177423

Locations


France
Assistance Publique - Hôpitaux de Marseille
Marseille, France

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators


Principal Investigator:	Herve TASSERY	Assistance Publique-Hôpitaux de Marseille

More Information


Responsible Party:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT01177423 History of Changes
Other Study ID Numbers:	2009-08 2009-A00684-53
Study First Received:	October 15, 2009
Last Updated:	August 28, 2014

Keywords provided by Assistance Publique Hopitaux De Marseille:


restorative odontology Patients cared in restorative odontology department

Additional relevant MeSH terms:


Toothache Tooth Diseases Stomatognathic Diseases Facial Pain Pain Neurologic Manifestations	Nervous System Diseases Signs and Symptoms Anesthetics Central Nervous System Depressants Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017